Patient interface and positioning and stabilising structure

Abstract

A patient interface includes a plenum chamber and at least three plenum chamber inlet ports. A seal-forming structure is arranged to form a seal at least at the entrance of the patient's nares and to maintain a therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle. The interface further includes a positioning and stabilising structure that includes at least four straps, at least three of which define a channel therein, with a conduit provided within each channel. Each conduit includes an interface connector for connecting the conduit to a respective one of the inlet ports and a connection port for connecting to an air circuit in use, with the connection port in fluid communication with each conduit. The plenum chamber is provided with at least one pressure measurement port. A positioning and stabilising structure is also disclosed.

Description

1 Background Technology 1.1 Technical Field

[0002] This technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses.

[0003] 1.2 Description of relevant technologies

[0004] 1.2.1 Human Respiratory System and Its Diseases

[0005] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0006] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from inhaled air and carbon dioxide to be expelled in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the airway tubes and do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, published in 2012 by John B. West, Lippincott Williams & Wilkins.

[0007] There is a range of respiratory disorders. Some disorders can be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0008] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0009] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes the affected patient to stop breathing, typically for periods ranging from 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can contribute to cardiovascular disease and brain damage. Concomitant symptoms are common, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a dysregulation of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0011] Respiratory failure is a term for a respiratory disorder in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

[0012] Patients with respiratory insufficiency (a form of respiratory failure) may experience unusual shortness of breath during exercise.

[0013] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0014] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These diseases include increased airflow resistance, prolonged expiratory phase, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0015] Neuromuscular disease (NMD) is a broad term encompassing many diseases and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular diseases can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive diseases: characterized by muscle damage that worsens within months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive diseases: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0016] The chest wall is a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0017] A range of treatments have been used to treat or improve these symptoms. Furthermore, other healthy individuals may utilize these treatments to prevent respiratory distress. However, these treatments have many drawbacks.

[0018] 1.2.2 Treatment

[0019] Various respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the aforementioned respiratory disorders.

[0020] 1.2.2.1 Respiratory pressure therapy

[0021] Respiratory pressure therapy involves supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy, such as that of a canister ventilator or endotracheal ventilator).

[0022] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, or if so, in any of these ways.

[0023] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive disease (NMD), and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0024] Non-invasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0025] 1.2.2.2 Flow Therapy

[0026] Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed respiratory volume by delivering an inspiratory flow rate profile (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy may supplement only the patient's own spontaneous breathing with a regulated or enriched flow of gas. In one example, high-flow therapy (HFT) delivers a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that remains approximately constant throughout the respiratory cycle. This therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow rate of air at the airway inlet improves ventilation efficiency by flushing or washing out exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as deadspace therapy (DST). Other benefits may include increased warmth and humidity (potentially beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to a constant flow rate, a therapeutic flow rate can follow a curve that varies throughout the respiratory cycle.

[0027] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. Doctors can prescribe a continuous flow of oxygen-enriched gas to the patient's airway at a specified oxygen concentration (from 21%, the oxygen fraction in ambient air, to 100%) and a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0028] 1.2.2.3 Oxygen Supplementation

[0029] For some patients, oxygen therapy can be combined with respiratory pressure therapy or HFT by adding supplemental oxygen to the pressurized airflow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.

[0030] 1.2.3 Respiratory Therapy System

[0031] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor a condition without treating it.

[0032] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0033] 1.2.3.1 Patient Interface

[0034] Patient interfaces can be used to attach breathing equipment to their wearer, for example, by providing an airflow into the airway inlet. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cm H2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cm H2O to the airway. For flow therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0035] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving may be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient.

[0036] Some masks may be clinically disadvantageous for this technique, such as those that block airflow through the nose and only allow it through the mouth.

[0037] If some masks require patients to insert a portion of the mask structure into their mouths to create and maintain a seal through their lips, this may be uncomfortable or impractical for this technology.

[0038] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0039] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during a period of breathing therapy.

[0040] Due to these challenges, some face shields suffer from one or more of the following problems: obtrusive, unattractive, expensive, mismatched, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized face shield can lead to reduced compliance, decreased comfort, and poorer patient outcomes. Face shields designed solely for pilots, those designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or those designed for administering anesthetics are acceptable for their original applications, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment. This is especially true if the face shield is worn during sleep.

[0041] Assuming patient adherence, nasal CPAP therapy is highly effective in treating certain breathing difficulties. Patients may not adhere to treatment if the mask is uncomfortable or difficult to use. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean it, which could affect adherence.

[0042] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0043] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0044] 1.2.3.1.1 Sealing Formation Structure

[0045] Patient interfaces may include seal-forming structures. Because they come into direct contact with the patient's face, the shape and construction of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0046] The patient interface can be partially characterized based on the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. This single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0047] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, because the shape, structure, variability, and sensitive areas of a patient's face differ. For instance, a seal on swimming goggles that cover a patient's forehead may not be suitable for use on a patient's nose.

[0048] Certain seal-forming structures can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0049] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface and the seal-forming portion engages face-to-face with the patient's face. The seal-forming structure may include an air- or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer (e.g., rubber). With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0050] Another type of seal-forming structure incorporates a sheet-like seal of thin material surrounding the periphery of the mask to provide a self-sealing effect on the patient's face when positive pressure is applied inside the mask. Similar to the previous type of seal-forming section, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or bend during use, causing leakage.

[0051] Another type of sealing structure may include friction-fitting elements, such as those for insertion into the nostrils; however, some patients find these uncomfortable.

[0052] Another form of seal formation can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0053] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0054] One form of nasal pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0055] ResMed manufactures the following products that include nose pillows: SWIFT™ Nose Pillow Cover, SWIFT™ II Nose Pillow Cover, SWIFT™ LT Nose Pillow Cover, SWIFT™ FX Nose Pillow Cover, and MIRAGE LIBERTY™ Full Face Cover. The following patent applications assigned to ResMed Limited describe examples of nose pillow masks: International Patent Application WO2004 / 073,778 (which describes other aspects of ResMed's SWIFT™ nose pillow), U.S. Patent Application 2009 / 0044808 (which describes other aspects of ResMed's SWIFT™ LT nose pillow); International Patent Applications WO 2005 / 063328 and WO 2006 / 130,903 (which describe aspects of ResMed's MIRAGE LIBERTY™ full-face mask); International Patent Application WO 2009 / 052,560 (which describes other aspects of ResMed's SWIFT™ FX nose pillow).

[0056] 1.2.3.1.2 Positioning and Stability

[0057] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0058] One technique involves using adhesives. See, for example, U.S. Patent Application Publication US2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0059] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following problems: unsuitability, bulkiness, discomfort, and inconvenience of use.

[0060] 1.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0061] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned treatments, for example, by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, RPT devices can also be used as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0062] Pneumatic generators are known in applications such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that more general pneumatic generators cannot meet, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may suffer from drawbacks related to one or more of comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0063] One example of a specific requirement for certain RPT devices is noise.

[0064] Noise output level table for existing RPT devices (for one sample only, measured at 10 cmH2O using the test method specified in ISO 3744 in CPAP mode).

[0065] RPT device name A-weighted sound pressure level dB(A) Year (approximately) <![CDATA[C Series Tango TM > 31.9 2007 <![CDATA[C-Series Tango with Humidifier TM > 33.1 2007 <![CDATA[S8 Escape TM II]]> 30.5 2005 <![CDATA[With H4i TM S8 Escape humidifier TM II]]> 31.1 2005 <![CDATA[S9 AutoSet TM ]]> 26.5 2010 <![CDATA[S9 AutoSet with H5i Humidifier TM > 28.6 2010

[0066] One known RPT device for treating sleep-disordered breathing is the ResMed S9 Sleep Therapy System. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar ventilator for adults and children, are also mentioned. TM The series can provide invasive and non-invasive non-dependent ventilation support for a range of patients to treat a variety of conditions, such as, but not limited to, NMD, OHS and COPD.

[0067] Elisée TM 150 ventilator and ResMed VS III TM Ventilators provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators offer volume ventilation and pressure ventilation modes with single-limb or dual-limb circuits.

[0068] RPT devices typically include a pressure generator, such as a motor-driven blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, the airflow can be supplied to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0069] The designer of the device may have provided an almost limitless number of options to make. Design standards often conflict, meaning that some design choices are unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute variations in one or more parameters.

[0070] 1.2.3.3 Air Circuit

[0071] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate branches of the air circuit for inspiratory and expiratory breathing. In other cases, a single-branch air circuit is used for both inspiratory and expiratory breathing.

[0072] Blockage of the air circuit must be avoided or mitigated (e.g., due to the patient lying on the catheter). In some known patient interfaces, the manifold is positioned on top of the patient's head, and the catheter extends from the manifold on either side of the patient's head into the air chamber. Because the patient can lie on one of these catheters, the catheter can be foldable to ensure the patient is not uncomfortable while lying on it. Therefore, if each opposing catheter becomes blocked, the size of each catheter must be set to carry a sufficient flow rate of air to maintain treatment pressure. This, in turn, means that the catheter must be relatively large. Using a large catheter can mean that the patient feels the interface has an inappropriate "medical" appearance and may lead to decreased adherence to the treatment schedule.

[0073] 1.2.3.4 Humidifier

[0074] Delivering airflow without humidification can lead to airway dryness. Humidifiers with an RPT device and patient interface produce humidified air, minimizing dryness of the nasal mucosa and increasing patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around it is generally more comfortable than cold air. Therefore, humidifiers typically have the ability to heat the airflow and humidify it.

[0075] Many artificial humidification devices and systems are known, however, they do not meet the specific requirements of medical humidifiers.

[0076] Medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air when needed, typically in areas where patients may sleep or rest (e.g., in hospitals). Bedside medical humidifiers can be small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, evaporative coolers, etc.) can also humidify the air inhaled by the patient; however, these systems also humidify and / or heat the entire room, which may make the occupant uncomfortable. Furthermore, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0077] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0078] 1.2.3.5 Oxygen Source

[0079] Experts in this field have recognized the long-term benefits of exercise for patients with respiratory failure, slowing disease progression, improving quality of life, and extending lifespan. However, most stationary forms of exercise, such as treadmills and stationary bikes, are too strenuous for these patients. Consequently, the need for mobility has long been recognized. Until recently, this mobility was facilitated by using small compressed oxygen canisters or cylinders mounted on trolleys with small wheels. The disadvantages of these canisters are that they contain a limited amount of oxygen and are heavy, weighing approximately 50 pounds when mounted.

[0080] Oxygen concentrators have been used for approximately 50 years to provide oxygen for respiratory therapy. Traditional oxygen concentrators are large and bulky, making ordinary mobile operations difficult and impractical. Recently, companies that manufacture large stationary oxygen concentrators have begun developing portable oxygen concentrators (POCs). The advantage of POCs is that they can produce a theoretically unlimited supply of oxygen. To make these devices highly mobile, various systems used to produce oxygen-enriched gas need to be condensed. POCs seek to utilize the oxygen they produce as efficiently as possible, minimizing weight, size, and power consumption. This can be achieved by delivering oxygen in a series of pulses, or “boli,” each boli timed to coincide with the start of inspiration. This mode of treatment is called pulsed or on-demand (oxygen) delivery (POD), in contrast to the traditional continuous flow delivery more suited to stationary oxygen concentrators.

[0081] 1.2.3.6 Data Management

[0082] There may be clinical reasons for obtaining data to determine whether a patient prescribed respiratory therapy has "adhered," such as the patient having used their RPT device according to one or more "adherence rules." An example of an adherence rule for CPAP therapy is that, to be considered adherent, a patient is required to use the RPT device for at least 4 hours per night for at least 21 days out of a 30-day period. To determine patient adherence, RPT device providers, such as healthcare providers, may manually obtain data describing the patient's treatment with the RPT device, calculate usage over the predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider can inform the patient of the third part of adherence.

[0083] There may be other aspects of patient treatment that would benefit from communication of treatment data to third-party or external systems.

[0084] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0085] 1.2.3.7 Vent Technology

[0086] Some forms of therapeutic systems may include vents to allow the flushing of exhaled carbon dioxide. Exhaust vents allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the external space of the patient interface, such as into the environment.

[0087] The vent may include an opening through which gas can flow during mask use. Many such vents are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vents may, for example, disturb the sleep of the patient's bed partner by causing noise or congested airflow.

[0088] ResMed Limited has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO 1998 / 034,665; and International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0089] 1.2.4 Screening, Diagnosis and Monitoring System

[0090] Polysomnography (PSG) is a routine system used for the diagnosis and monitoring of cardiopulmonary diseases and typically involves specialized clinicians applying the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). PSG for sleep-disordered breathing involves two nights of clinical observation: one night for pure diagnosis and the second night for a clinician to titrate treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0091] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically yields a true / false result, indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis tend to be one-off processes, while monitoring disease progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0092] Clinicians may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where clinicians may be unavailable or unaffordable. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. 2. Summary of the Invention

[0093] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0094] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0095] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0096] One aspect of this technology in certain forms is used to provide methods and / or devices for improving patient compliance with respiratory therapy.

[0097] One form of this technology includes a patient interface, which includes:

[0098] An air chamber that can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure;

[0099] It has at least three inlet ports for the air chamber, sized and designed to receive airflow under therapeutic pressure for the patient's breathing.

[0100] A sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet. The sealing structure has an opening therein, allowing airflow at the therapeutic pressure to be delivered at least to the inlet of the patient's nostrils. The sealing structure is configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0101] as well as

[0102] A positioning and stabilizing structure includes at least four straps, at least three of which define channels therein, wherein a conduit is provided within each channel, and each conduit includes an interface connector for connecting the conduit to a corresponding inlet port in use. The positioning and stabilizing structure further includes a connection port for connecting to an air circuit in use, wherein the connection port is in fluid communication with each of the conduits.

[0103] The inflation chamber is provided with at least one pressure measuring port. In the example:

[0104] a) Each catheter has a diameter of 5 mm or less; b) Each band comprises two layers of material, with a channel disposed between the layers; c) Each band includes a connector along one edge of the band; d) Each band includes a first connector along one edge of the band and a second connector along the opposite edge of the band; f) Each catheter is completely enclosed within the corresponding band; g) The catheter is separated from the band; and / or h) The catheter does not contribute to the interface carrier.

[0105] Another form of the technology includes a positioning and stabilization structure for the patient interface, the structure comprising at least four straps, each of which can be connected to the patient interface.

[0106] Each of the straps comprises two or more layers of material arranged to define a channel therebetween, wherein a catheter is disposed within each channel, and each catheter includes an interface connector for connecting the catheter to a corresponding inlet port of the patient interface in use. The positioning and stabilizing structure further includes a connection port for connecting to an air circuit in use, wherein the connection port is in fluid communication with each of the catheters.

[0107] In the example:

[0108] a) Each catheter has a diameter of 5 mm or less; b) Each band includes a connector along one edge of the band; c) Each band includes a first connector along one edge of the band and a second connector along the opposite edge of the band; d) Each catheter is completely enclosed within the corresponding band; and / or e) The catheter is detached from the band such that, in use, the catheter does not contribute to the interface carrier.

[0109] Another form of this technology includes a patient interface, which includes:

[0110] The air chamber can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure.

[0111] A sealing structure is configured and arranged to seal with a patient facial area around an inlet to the patient's airway, the sealing structure having at least one opening therein to allow an airflow under the therapeutic pressure to be delivered to the patient's mouth and nostrils, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0112] in

[0113] The inflation chamber is provided with at least one nasal inlet port and at least one oral inlet port, the nasal inlet port and oral inlet port being sized and configured to receive a corresponding airflow under therapeutic pressure for breathing by the patient, wherein the nasal inlet port is positioned closer to the patient's nostrils in use than the oral inlet port.

[0114] Another form of this technology includes a patient interface, which includes:

[0115] The air chamber can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure.

[0116] A first sealing structure is connected to the opening portion of the inflation chamber and is configured and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's mouth, such that an airflow under the treatment pressure is delivered to the patient's mouth. The sealing structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's respiratory cycle during use.

[0117] A second sealing structure is connected to the nasal portion of the inflatable chamber and is configured and arranged to form a seal with the area of ​​the patient’s face surrounding the patient’s nasal inlet, such that an airflow under the therapeutic pressure is delivered to the patient’s nose. The sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient’s respiratory cycle during use.

[0118] The nose portion of the inflatable chamber is provided with at least one nose inlet port, and the mouth portion of the inflatable chamber is provided with at least one mouth inlet port.

[0119] Another form of this technology includes a patient interface, which includes:

[0120] The air chamber can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure.

[0121] A first sealing structure is configured and arranged to form a seal with a region of the patient’s face surrounding the entrance to the patient’s mouth, such that an airflow under the treatment pressure is delivered to the patient’s mouth, the sealing structure being configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient’s respiratory cycle during use;

[0122] The second sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the patient's nasal inlet, such that an airflow under the treatment pressure is delivered to the patient's nose, and the sealing structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's respiratory cycle during use;

[0123] The air chamber is provided with a nose inlet port and a mouth inlet port, wherein the nose inlet port is higher than the mouth inlet port.

[0124] In the example:

[0125] a) The patient interface is configured such that, in use, the flow rate of air to the patient's nostrils is greater than the flow rate to the patient's mouth; b) the impedance of said or each nasal inlet port is different from the impedance of said or each oral inlet port; c) the interface includes a plurality of nasal inlet ports and a plurality of oral inlet ports, the combined impedance of the nasal inlet ports being less than the combined impedance of the oral inlet ports; d) the flow rate through at least one of these inlet ports is adjustable; e) the flow rate through at least one of these inlet ports is continuously adjustable; f) at least one inlet port includes a flow restrictor; g) said flow restrictor is releasably connected to said patient interface; and / or h) the patient interface includes a pressure measurement port.

[0126] Another form of this technology includes a system for supplying a patient with air at a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, the system comprising:

[0127] The patient interface as defined in any of the paragraphs above, wherein the inflatable chamber is provided with at least one pressure measurement port, the patient interface further includes positioning and stabilizing structures to provide forces for holding the sealing structure in a therapeutically effective position on the patient's head;

[0128] RPT device; and

[0129] The air circuit connecting the RPT device and the patient interface.

[0130] The RPT device changes the flow rate through the air circuit and / or through one of these inlet ports in response to a pressure change measured at at least one pressure measurement port.

[0131] In the example:

[0132] a) The RPT device includes at least one pressure sensor port, wherein each pressure measurement port of the patient interface is fluidly connected to a corresponding pressure sensor of the RPT device via a corresponding pressure signal conduit;

[0133] b) The inflation chamber is provided with a first pressure measurement port and a second pressure measurement port, the first pressure measurement port being used to measure the pressure of the air supplied to the patient's mouth during use, and the second pressure measurement port being used to measure the pressure of the air supplied to the patient's nostrils during use; c) A pressure transducer is installed to said or each pressure measurement port; d) The RPT device controls the total flow rate of air supplied to said or each nasal inlet port to be greater than the total flow rate of air supplied to said or each oral inlet port; and / or f) at least one nasal inlet port and / or at least one or at least one of said oral ports includes an electronically adjustable valve, wherein the RPT device controls the setting of each valve.

[0134] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0135] One aspect of this technology is a method of manufacturing an apparatus.

[0136] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for use by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.

[0137] One aspect of this technology is a patient interface that can be cleaned in a patient's home, for example, with soapy water, without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier canister that can be cleaned in a patient's home, for example, with soapy water, without requiring specialized cleaning equipment.

[0138] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0139] Of course, some of these aspects can form sub-aspects of this technology. Sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0140] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. 3. Attached Figure Descriptions

[0141] This technology is illustrated by way of example and not limitation in the figures, and similar reference numerals in the figures refer to similar elements, including:

[0142] 3.1 Respiratory Therapy System

[0143] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device 4000 is conditioned in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient sleeps in a supine position.

[0144] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0145] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.

[0146] 3.2 Respiratory System and Facial Anatomy

[0147] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0148] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0149] Figure 2C It is a frontal view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0150] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, supraauricular base, and subauricular base. The vertical and anteroposterior directions are also marked.

[0151] Figure 2E This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also shown.

[0152] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial folds, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0153] Figure 2G A side view showing the surface features of the nose.

[0154] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0155] Figure 2I The diagram shows the medial anatomy of the nose a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0156] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal turbinate bones, as well as the maxilla and mandible, are also indicated.

[0157] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0158] Figure 2L The frontal lateral view of the nose is shown.

[0159] 3.3 Patient Interface

[0160] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0161] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0162] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0163] Figure 3D A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a zero value.

[0164] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0165] Figure 3F A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0166] Figure 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are shown. The vaulted and saddle-shaped areas are shown.

[0167] Figure 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edges of the surface are shown. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0168] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0169] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown is in Figure 3I The structure defines a two-dimensional hole.

[0170] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... Figure 3I The surface of the two-dimensional hole is defined in the structure.

[0171] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0172] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the air bladder is also shown. The inner surface defines two-dimensional openings in the mask.

[0173] Figure 3N Showing through Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0174] Figure 3O The left-hand rule is shown.

[0175] Figure 3P The right-hand rule is shown.

[0176] Figure 3Q The left ear is shown, including the left ear spiral.

[0177] Figure 3R The right ear is shown, including the right ear spiral.

[0178] Figure 3S A right-handed spiral is shown.

[0179] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0180] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0181] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the central contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts, left and right.

[0182] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is in Figure 3VThe image shows a section taken at the sagittal plane. The "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and makes contact with the gasket of the inflation chamber at two points on the sagittal plane: upper point 3220 and lower point 3230.

[0183] Depending on the geometry of the padding in the area, the intermediate contact plane can be a tangent at the upper and lower points.

[0184] Figure 3X It shows Figure 3U The position of the inflation chamber 3200 on the face. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 approximately coincides with the midsagittal plane of the face. When the inflation chamber is in the use position, the intermediate contact plane generally corresponds to the 'facial plane'. Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the root of the nose, while the lower point 3230 is located on the upper lip.

[0185] 3.4RPT device

[0186] Figure 4A An RPT device of one form according to the present technology is shown.

[0187] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface as downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0188] Figure 4C A schematic diagram of the electrical components of one form of RPT device according to the present technology is shown.

[0189] 3.5 Humidifier

[0190] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0191] Figure 5B An isometric view of a humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0192] 3.6 Respiratory waveform

[0193] Figure 6A The diagram shows a typical breathing waveform of a person during sleep.

[0194] 3.7 Patient Interface Example of This Technology

[0195] Figure 7 A rear perspective view of an inflatable chamber according to the present technology is shown.

[0196] Figure 8 A front perspective view of a form of patient interface according to this technology is shown in use.

[0197] Figure 9 It shows Figure 8 The patient interface is shown in the side view during use.

[0198] Figure 10 It shows Figure 8 The patient interface is shown in the back view during use.

[0199] Figure 11 A cross-sectional view of one form of headband strap according to the present technology is shown.

[0200] Figure 12 A cross-sectional view of another form of headband strap according to the present technology is shown.

[0201] Figure 13 A cross-sectional view of another form of headband strap according to the present technology is shown. 4. Detailed Implementation

[0202] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this invention is for the purpose of describing the specific examples discussed herein and is not intended to be limiting.

[0203] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. In addition, in any example, any single feature or combination of features may constitute another example.

[0204] 4.1 Treatment

[0205] In one form, the technology includes a method for treating respiratory disorders, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0206] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0207] In some examples of this technique, mouth breathing is limited, restricted, or prevented.

[0208] 4.2 Respiratory Therapy System

[0209] In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0210] 4.3 Patient Interface

[0211] According to one aspect of the present technology, the noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an airway 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the airway inlet of the patient 1000. The sealed patient interface 3000 is therefore suitable for the delivery of positive pressure therapy.

[0212] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0213] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 6 cm H2O relative to the environment.

[0214] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 10 cm H2O relative to the environment.

[0215] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 20 cm H2O relative to the environment.

[0216] In this example of the technology, the patient interface does not extend above the patient's nasal ridge.

[0217] 4.3.1 Sealing Formation Structure

[0218] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the position of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0219] like Figure 7 As best illustrated herein, in certain forms of the invention, the sealing forming structure 3100 includes a first sealing forming structure 3101 connected to the mouth portion 3201 of the inflation chamber 3200 and configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's mouth; and a second sealing forming structure 3102 connected to the nose portion 3202 of the inflation chamber 3200, configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's nose. The phrase "connected to" herein is used to refer to parts or components formed as a single piece as well as parts or components formed separately and subsequently joined together. In some cases, components may be connected via intermediate components.

[0220] In the example, the sealing structure forms a seal with a portion of the user's nostril, located on the lower side of the user's nose below the nasal ridge.

[0221] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0222] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material such as silicone rubber.

[0223] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material, such as silicon.

[0224] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure being configured to correspond to a different size and / or shape range. For example, the system may include one type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0225] 4.3.1.1 Sealing Mechanism

[0226] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting on its bottom surface within the inflation chamber 3200, thereby forming a tight seal with the face. This pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.

[0227] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the circumference. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0228] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and positioned in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0229] In one form, the sealing structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0230] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0231] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

[0232] 4.3.1.2 Nasal bridge or nasal ridge area

[0233] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the bridge or ridge of the nose of the patient's face during use.

[0234] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the bridge or ridge of the nose of a patient's face.

[0235] 4.3.1.3 Upper lip area

[0236] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that, in use, forms a seal on the upper lip region (i.e., the upper lip) of the patient's face.

[0237] In one embodiment, the sealing structure includes a saddle-shaped region configured to form a seal on the upper lip region of a patient's face during use.

[0238] 4.3.1.4 Chin area

[0239] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that, during use, forms a seal on the chin region of the patient's face.

[0240] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on the chin area of ​​a patient's face.

[0241] 4.3.1.5 Forehead area

[0242] In one form, the sealing structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.

[0243] 4.3.1.6 Nasal pillow

[0244] In one embodiment, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is configured and arranged to form a seal with the corresponding nostril of the patient's nose.

[0245] A nasal pillow according to one aspect of the present technology includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow connection structure of the present technology includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of both the truncated cone and the nasal pillow connection structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the handle connection structure.

[0246] 4.3.2 Inflation Chamber

[0247] In the area forming a seal during use, the air chamber 3200 has a periphery shaped to complement the surface contours of a typical human face. During use, the boundary edges of the air chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend along the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 and the sealing structure 3100 are formed from a single sheet of homogeneous material.

[0248] In some forms of this technology, the air chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chamber. Such a form tends to be less conspicuous and / or more comfortable for the wearer, which can improve treatment compliance.

[0249] In some forms of this technology, the air chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve treatment adherence. The transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0250] In some forms of this technology, the air chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve treatment adherence.

[0251] As described above, in some forms of this technology, the air chamber may include a mouth portion 3201 and a nose portion 3202.

[0252] 4.3.3 Entry Port

[0253] The following is for reference. Figure 8 and 9 In some forms of this technology, the inflation chamber 3200 is provided with multiple inlet ports. In an example, the inflation chamber 3200 is provided with at least one nasal inlet port 3602 and at least one oral inlet port 3604. In use, the nasal inlet port 3602, or each nasal inlet port, is positioned closer to the patient's nostrils than the oral inlet port 3604, or each oral inlet port.

[0254] In some forms of this technology, the nasal inlet port 3602 is superior to the oral inlet port 3604 in use.

[0255] In the example, multiple nose inlet ports 3602 and / or multiple mouth inlet ports 3604 are provided. Each nose inlet port 3602 may be located at substantially the same position in the vertical direction, i.e., at substantially the same "height". Each mouth inlet port 3604 may be located at substantially the same position in the vertical direction as the other mouth inlet ports 3604.

[0256] In one embodiment, two nasal inlet ports 3602 and two oral inlet ports 3604 are provided. The nasal inlet ports 3602 may be higher than the oral inlet ports 3604.

[0257] In the example, the inlet port 3604 can be configured to provide a different impedance to the airflow than the nose inlet port 3602. For example, the inlet port 3604 can have a greater impedance than the nose inlet port 3602. The greater impedance can be a result of the flow path at the inlet port 3604 having a smaller cross-sectional area.

[0258] In one example, the number of provided nasal inlet ports 3602 may differ from the number of oral inlet ports 3604. In such an example, the total impedance or combined impedance of the oral inlet ports 3604 may differ from the total impedance of the nasal inlet ports 3602. In one example (not shown), the inflation chamber 3200 may be provided with two nasal inlet ports 3602, but only a single oral inlet port 3604. If all ports 3602, 3604 are supplied with air at the same pressure, the nasal inlet ports 3602 may be configured to allow a larger total volumetric flow rate (e.g., the sum of the flow rates through the two nasal inlet ports) than the flow through the oral inlet port 3604. This arrangement may facilitate nasal breathing in the patient, for example by increasing the air pressure at the patient's nostril inlet relative to the pressure at the patient's mouth inlet and / or may improve flushing near the patient's nostril inlet.

[0259] In the example, one or more nasal inlet ports 3602 and / or one or more oral inlet ports 3604 may be provided with valves (not shown) configured to allow adjustment of the flow rate through the inlet ports 3602, 3604 as needed. The valve may be a valve that can be manually adjusted by a user, or a valve that can be electronically adjusted (e.g., continuously electronically adjusted) by, for example, a controller of the RPT device, in response to pressure measurements within the inflation chamber. As further described below, in another example, an adjustable valve may be provided to a conduit supplying a single port, or a conduit supplying a set of ports (e.g., oral inlet port 3604 or nasal inlet port 3602). In one embodiment, the valve, or each valve, may be adjusted based on the pressure within the inflation chamber 3200, or the pressure within a relevant portion of the inflation chamber (e.g., oral portion 3201 and / or nasal portion 3202). In one example, pressure may be measured at multiple locations within the inflation chamber 3200. For example, one location may allow measurement of the air pressure supplied to the patient's nostrils, while a second location may allow measurement of the air pressure supplied to the patient's mouth.

[0260] In one embodiment, one or more of ports 3602, 3604 may be provided with a current limiter, such as a component having an orifice therethrough having a smaller cross-sectional area than the remainder of the flow path through ports 3602, 3604. The current limiter can permanently or semi-permanently alter the impedance of the port. In some such embodiments, the current limiter can be releasably connected to the patient interface. In one embodiment, the current limiter can be selected and / or installed by a technician rather than a patient.

[0261] In one embodiment, the patient side of one or more inlet ports 3602, 3604 may be shaped to guide airflow in a particular direction. For example, the patient side of the nasal inlet port 3602 may be shaped to guide flow toward the patient's nostrils.

[0262] In some forms of this technology, these inlet ports 3602, 3604 can be configured to improve the flushing of the inflation chamber, or at least improve the flushing of the portion of the inflation chamber that supplies air to the patient's airway.

[0263] 4.3.4 Pressure Measurement

[0264] In one example, the patient interface may include a pressure measurement port 3606. In this example, the inflation chamber may be provided with the pressure measurement port 3606. In this example, the pressure measurement port 3606 is spaced apart from each inlet port. In one form of the technology, the pressure measurement port 3606 is located in or near the midsagittal plane. In another example, the pressure measurement port 3606 is located adjacent to the patient's nostrils.

[0265] In some forms of this technology, two pressure measurement ports 3606 may be provided. In some examples, one of the pressure measurement ports 3606 may be positioned to allow measurement of pressure in a region adjacent to the patient's nostrils, while the other may be positioned to allow measurement of pressure in a region adjacent to the patient's mouth.

[0266] In some forms of this technology, the pressure measurement port 3606 may be in fluid communication with a remote pressure measurement sensor, such as a sensor provided to the RPT device. A corresponding pressure signal conduit 3608 may fluidly connect each pressure measurement port 3606 to a corresponding pressure sensor port 4002 of the RPT device. In the example, when the interface is used, there is essentially no flow through the pressure signal conduit 3608; for example, pressure signal conduit 3608 is not supplied with pressurized air by the RPT except to the extent that pressurized air enters the pressure signal conduit 3608 via the pressure measurement port 3606.

[0267] In other forms of this technology, the pressure sensor can be directly mounted to one or more pressure measurement ports 3606, and / or the pressure sensor can be positioned inside the inflation chamber 3200 at any location suitable for the pressure measurement port 3606.

[0268] The RPT device can respond to pressure changes within the inflation chamber 3200, such as those measured via pressure measurement port 3606 and / or via a transducer connected to or disposed within the inflation chamber 3200, by altering the flow rate supplied to one or more inlet ports 3602, 3604, or a selected group of inlet ports (e.g., nose inlet port 3602). In this example, the RPT device alters the flow rate to the inlet ports by changing the signal to an electronically variable valve.

[0269] 4.3.5 Positioning and Stabilization Structure

[0270] The sealing structure 3100 of the patient interface 3000 of this technology can be kept in a sealed state during use by positioning and stabilizing structure 3300.

[0271] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face away.

[0272] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0273] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0274] In one form of this technology, a positioning and stabilization structure 3300 is provided, constructed in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one example, the positioning and stabilization structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0275] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a supine sleeping position, wherein the back area of ​​the patient's head is on a pillow.

[0276] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a side-sleeping position, wherein the lateral area of ​​the patient's head is on the pillow.

[0277] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible or loose bandage. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0278] In one form of this technology, the positioning and stabilizing structure 3300 includes a strip constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strip. In one form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0279] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to be tensioned during use and to guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In an example, the strap may be configured as a tie.

[0280] In one form of the present technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the base of the upper ear on the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0281] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second strap that is configured and arranged such that, in use, at least a portion of the upper edge of the second strap passes below the base of the lower ear on the patient's head and covers or is located below the occipital bone of the patient's head.

[0282] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0283] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is flexible and, for example, non-rigid. An advantage of this is that the strap makes it more comfortable for the patient to lie on it while sleeping.

[0284] In some forms of this technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow moisture to be transferred through the straps.

[0285] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0286] 4.3.6 Guide tubes installed inside the hood

[0287] In one form of this technology, the positioning and stabilizing structure 3300 includes a headband 3302. In an example, the headband 3302 includes a pair of upper straps 3304 and a pair of lower straps 3306. The upper straps 3304 and lower straps 3306 are connected to or can be connected to an inflation chamber 3200 of the patient interface. In an example, the lower straps 3306 can be connected to each other to form a loop. In an example, the upper straps 3304 can be connected to each other to form a loop. Additionally or alternatively, the upper and / or lower straps 3304, 3306 can be connected to another headband component, such as a crown strap 3308, as... Figure 10 As shown in the best example.

[0288] In the example, one or both of the upper and lower headband straps 3304 and 3306 define the channel 3310 therein. In one example, as Figure 11 As shown, headband straps 3304, 3306 include a first material layer 3312, which is connected to a second material layer 3314 via a connector 3316 extending along each side edge of the strap. Each layer 3312, 3314 may include a separate sheet of material. In other examples, such as Figure 12 As shown, the single piece of material can be folded to form two layers 3312, 3314, wherein the joint 3316 extends downward only along one side of the strap. The joint, or each joint 3316, can be achieved by any suitable joining technique, such as stitching, gluing, or ultrasonic die-cutting.

[0289] like Figure 13 As shown, in one form of this technology, one or more of the headband straps 3304, 3306 may be formed by knitting and / or additive manufacturing techniques to define a channel therein without the need for joining along its lateral sides, although in some examples the straps thus formed may be joined to one or more other straps by suitable joining techniques.

[0290] In the example, each of the upper and lower headband straps 3304, 3306 has a catheter 3610 disposed within a channel 3310 defined by the strap. In this embodiment, each catheter 3610 has a relatively small diameter, for example, 4-5 mm. Using such a small-diameter catheter 3610 can reduce discomfort felt by the patient if the patient lies on one of the catheters. Each catheter 3610 may include an interface connector 3612 that can be connected to an inlet port 3602, 3604.

[0291] In examples where only three of these small-diameter catheters 3610 are provided with connections to three inlet ports 3602, 3604, it may be necessary to provide at least one pressure measurement port 3606 for the inflation chamber 3200, as described herein, to allow monitoring of the pressure within the inflation chamber to ensure sufficient airflow is provided to the inflation chamber 3200 to maintain therapeutic pressure, for example, if one of the catheters 3610 becomes blocked due to a patient lying on the catheter. In examples with four inlet catheters 3610 connected to four inlet ports 3602, 3604, if one catheter becomes blocked, the flow through the remaining three catheters may be sufficient to eliminate the need for pressure sensing of the inflation chamber 3200 via the pressure measurement port 3606. Therefore, in some examples of the inflation chamber 3200 with four inlet ports 3602, 3604, a pressure measurement port may not be provided.

[0292] In the example, the catheter 3610 within the upper and / or lower headband straps 3304, 3306 is substantially completely enclosed within the headband straps 3304, 3306; that is, virtually no part of the corresponding catheter 3610 is visible (except for the optional connector). This can help make the patient interface 3000 look less like a medical device, which in turn can improve patient adherence to prescribed treatment protocols.

[0293] In the example, conduit 3610 is disposed within the upper and lower headband straps 3304 and 3306, but is separated from the corresponding straps at least in the axial direction, so that conduit 3610 is not under tensile load during use; that is, in the example, conduit 3610 does not contribute to the interface carrier. In the example, conduit 3610 is arranged within channel 3310 such that adjustment of the headband does not affect the impedance of the corresponding conduit 3610.

[0294] The catheter 3610 can be directly connected to the manifold 3614, which includes the connection port 3600. In other examples, an intermediate catheter can be provided between the catheter 3610 and the manifold 3614. For example, an intermediate catheter can be provided on each side of the patient's head, each intermediate catheter connecting to an upper catheter 3616 (e.g., catheter 3610 within the upper bandage 3304) and a lower catheter 3618 (e.g., catheter 3610 within the lower bandage 3304) on the same side of the head, for example, via a Y-connector.

[0295] In the example, the upper conduit 3616 may have substantially the same impedance as the lower conduit 3618. However, in other forms of the technique, the upper conduit 3616 may have a different impedance than the lower conduit 3618. In one form of the technique, the upper conduit 3616 may have a lower impedance than the lower conduit 3618, for example, due to having a relatively larger inner diameter. This can result in different flow rates being delivered to different regions of the inflation chamber 3200; for example, the conduit supplying the nasal inlet port 3602 of the inflation chamber may provide a greater flow rate than the conduit supplying the oral inlet port 3604 of the inflation chamber 3200.

[0296] In the example, because the upper and lower catheters 3616 and 3618 are separated from each other, even if one catheter is blocked (e.g., because the patient is lying on it), the other catheters are unlikely to be blocked, and therefore sufficient total flow will still be provided to the inflation chamber.

[0297] 4.3.7 Vent

[0298] In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0299] In some configurations, the airway 3400 is configured to allow continuous ventilation flow from the interior of the inflation chamber 3200 to the surrounding environment, while the pressure within the inflation chamber is positive relative to the surrounding environment. The airway 3400 is configured such that the airway flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the therapeutic pressure within the inflation chamber during use.

[0300] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0301] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a decoupling structure, such as a rotary joint.

[0302] 4.3.8 Decoupling Structure

[0303] In one embodiment, the patient interface 3000 includes at least one decoupling structure, such as a swivel or ball joint and socket. In the example, the decoupling structure is disposed between the connection port 3600 and the manifold.

[0304] 4.3.9 Connection Port

[0305] Connection port 3600 allows connection to air circuit 4170.

[0306] 4.3.10 Forehead Stent

[0307] In one configuration, the patient interface 3000 includes a forehead support 3700. In this example, no forehead support is provided.

[0308] 4.3.11 Anti-asphyxiation valve

[0309] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0310] 4.3.12 port

[0311] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0312] 4.4RPT device

[0313] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to execute one or more algorithms, such as any of the methods described herein in whole or in part. The RPT device 4000 can be configured to generate an airflow for delivery to a patient's airway, for example, for treating one or more respiratory conditions described elsewhere in this document.

[0314] In one embodiment, the RPT device 4000 is configured and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0315] The RPT device may have an outer housing 4010, which is composed of two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018. In some examples, a pressure sensor port 4002 may be provided to the outer housing 4010, which is in fluid communication with a pressure sensor.

[0316] The pneumatic path of the RPT device 4000 may include one or more air path objects, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0317] One or more air path components may be housed within a detachable, separate structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be housed within an outer housing 4010. In one embodiment, pneumatic block 4020 is supported by, or forms part of, a chassis 4016.

[0318] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller, a pressure generator 4140, one or more protection circuits, a memory, a converter 4270, a data communication interface, and one or more output devices. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA). In an alternative form, the RPT device 4000 may include more than one PCBA.

[0319] In one embodiment, the RPT device may include one or more pressure sensor ports 4002, each configured to connect to a corresponding pressure signal conduit 3608. Each pressure sensor port 4002 may be in fluid communication with a pressure transducer or a corresponding pressure transducer to allow measurement of pressure in the corresponding pressure signal conduit 3608, and thus measurement of pressure within or a portion of the inflation chamber.

[0320] 4.4.1 Mechanical and pneumatic components of the RPT device

[0321] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be configured as separate units.

[0322] 4.4.1.1 Air Filter

[0323] One form of RPT device according to the present technology may include one air filter 4110, or multiple air filters 4110.

[0324] In one configuration, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0325] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0326] 4.4.1.2 Muffler

[0327] One form of RPT device according to the present technology may include one or more mufflers 4120.

[0328] In one embodiment of this technology, the inlet silencer 4122 is positioned in the pneumatic path upstream of the pressure generator 4140.

[0329] In one embodiment of this technology, the outlet silencer 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface.

[0330] 4.4.1.3 Pressure Generator

[0331] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor having one or more impellers. These impellers may be located in a volute. The blower can deliver an air supply, for example, at a rate up to about 120 liters / minute and at a positive pressure ranging from about 4 cm H2O to about 20 cm H2O, or in other forms up to about 30 cm H2O, for example, when delivering respiratory pressure therapy. The blower may be as described in any of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT

[0332] Patent Application No. WO 2013 / 020167.

[0333] The pressure generator 4140 is under the control of the treatment device controller.

[0334] In other words, the pressure generator 4140 can be a piston-driven pump, a pressure regulator (e.g., a compressed air reservoir) connected to a high-pressure source, or a bellows.

[0335] 4.4.1.4 Transducer

[0336] The transducer can be inside or outside the RPT device. An external transducer can be located, for example, on or form part of an air circuit such as a patient interface. The external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0337] In one embodiment of this technology, one or more transducers 4270 may be positioned upstream and / or downstream of pressure generator 4140. One or more transducers 4270 may be configured and arranged to generate a signal representing airflow characteristics such as flow rate, pressure, or temperature at that point in the pneumatic path.

[0338] In one form of this technology, one or more converters 4270 may be positioned proximal to the patient interface 3000.

[0339] In one embodiment, the signal from transducer 4270 may be filtered, for example, by low-pass filtering, high-pass filtering, or band-pass filtering.

[0340] 4.4.1.4.1 Flow rate sensor

[0341] The flow rate sensor according to this technology can be based on a differential pressure transducer, such as the SDP600 series differential pressure transducer from SENSIRION.

[0342] In one configuration, a signal generated by a flow rate sensor and representing the flow rate is received by a central controller 4230.

[0343] 4.4.1.4.2 Pressure Sensor

[0344] The pressure sensor according to this technology is positioned in fluid communication with the pneumatic path. A suitable example of a pressure sensor is a transducer from the HONEYWELL ASDX series. An alternative suitable pressure sensor is a transducer from the GENERALELECTRIC NPA series.

[0345] In one configuration, the signal generated from the pressure sensor can be received by the central controller 4230.

[0346] 4.4.1.4.3 Motor Speed ​​Converter

[0347] In one form of this technology, a motor speed transducer is used to determine the rotational speed of the electric motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer can be provided to the treatment device controller. The motor speed transducer can be, for example, a speed sensor, such as a Hall effect sensor.

[0348] 4.4.1.5 Anti-overflow valve

[0349] In one embodiment of this technology, an anti-backflow valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the electric motor 4144.

[0350] 4.4.2 Electrical components of the RPT device

[0351] 4.4.2.1 Power Supply

[0352] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0353] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of the invention, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0354] 4.4.2.2 Input Device

[0355] In one form of this technology, the RPT device 4000 includes one or more input devices in the form of buttons, switches, or dials to allow personnel to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessed via a touchscreen. In one form, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another form, they can communicate wirelessly with a receiver electrically connected to a central controller 4230.

[0356] In one form, the input device may be constructed or arranged to allow a person to select values ​​and / or menu options.

[0357] 4.4.2.3 Central Controller

[0358] In one form of this technology, the central controller 4230 is one or more processors adapted to control the RPT device 4000.

[0359] Suitable processors may include x86 Intel processors, based on those from ARM Holdings. Processors with an M-bit RISC CPU, such as the STM32 series microcontrollers from ST Microelectronics, are also suitable. In some alternative forms of this technology, processors with a 32-bit RISC CPU, such as the STR9 series microcontrollers from ST Microelectronics, or a 16-bit RISC CPU, such as the MSP430 series microcontrollers from Texas Instruments, are equally applicable.

[0360] In one form of this technology, the central controller 4230 is a dedicated electronic circuit.

[0361] In one form, the central controller 4230 is an application-specific integrated circuit (ASIC). In another form, the central controller 4230 includes discrete electronic components.

[0362] The central controller 4230 can be configured to receive input signals from one or more transducers 4270, one or more input devices, and humidifier 5000.

[0363] The central controller 4230 can be configured to provide output signals to one or more output devices 4290, treatment device controllers, data communication interfaces, and humidifiers 5000.

[0364] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms represented as computer programs stored in a non-transitory computer-readable storage medium such as memory. In some forms of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed by a remote positioning device. For example, the remote positioning device may determine ventilator control settings or detect respiratory-related events by analyzing stored data such as from any of the sensors described herein.

[0365] 4.4.2.4 Clock

[0366] The RPT device 4000 may include a clock connected to the central controller 4230.

[0367] 4.4.2.5 Treatment device controller

[0368] In one form of this technology, the treatment device controller is a treatment control module that constitutes part of an algorithm executed by the central controller 4230.

[0369] In one form of this technology, the treatment device controller is a dedicated motor control integrated circuit. For example, in one form, the MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0370] 4.4.2.6 Protection Circuit

[0371] One or more protection circuits according to this technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0372] 4.4.2.7 Memory

[0373] According to one embodiment of the present technology, the RPT device 4000 includes a memory, such as non-volatile memory. In some embodiments, the memory may include battery-powered static RAM. In some embodiments, the memory may include volatile RAM.

[0374] The memory can be located on PCBA 4202. The memory can be in the form of EEPROM or NAND flash memory.

[0375] Alternatively or alternatively, the RPT device 4000 may include removable memory, such as a memory card made according to the Secure Digital (SD) standard.

[0376] In one form of this technology, the memory is used as a non-transitory computer-readable storage medium on which computer program instructions, such as one or more algorithms, representing one or more methods described herein are stored.

[0377] 4.4.2.8 Data Communication System

[0378] In one form of this technology, a data communication interface is provided and connected to a central controller 4230. The data communication interface can be connected to a remote external communication network and / or a local external communication network. The remote external communication network can be connected to a remote external device. The local external communication network can be connected to a local external device.

[0379] In one embodiment, the data communication interface is part of the central controller 4230. In another embodiment, the data communication interface is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0380] In one form, the remote external communication network is the Internet. The data communication interface can connect to the Internet using wired communication (e.g., via Ethernet or fiber optic) or wireless protocols (e.g., CDMA, GSM, LTE).

[0381] In one form, the local external communication network utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols.

[0382] In one form, the remote external device can be one or more computers, such as a cluster of networked computers. In another form, the remote external device can be a virtual computer rather than a physical computer. In either case, this remote external device can be accessed by appropriately authorized personnel, such as clinicians.

[0383] Local external devices can be personal computers, mobile phones, tablets, or remote control devices.

[0384] 4.4.2.9 Includes optional display and alarm output devices.

[0385] The output device 4290 according to this technology can take the form of one or more of visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0386] 4.4.2.9.1 Display Driver

[0387] The display driver receives characters, symbols, or images as input for display on the display and converts them into commands that cause the display to show those characters, symbols, or images.

[0388] 4.4.2.9.2 Monitor

[0389] The display is configured to visually display characters, symbols, or images in response to commands received from a display driver. For example, the display may be an eight-segment display, in which case the display driver converts each character or symbol (such as the number "0") into eight logic signals that indicate whether the eight corresponding segments will be activated to display a specific character or symbol.

[0390] 4.5 Air Circuit

[0391] According to one aspect of the art, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow to travel between two components, such as the RPT device 4000 and the patient interface 3000.

[0392] Specifically, the air circuit 4170 can be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may be referred to as an air delivery tube. In some cases, it may have separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0393] In some forms, the air circuit 4170 may include one or more heating elements configured to heat air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating element may be connected to a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0394] 4.5.1 Supplemental Gas Delivery

[0395] In one form of this technology, supplemental gas, namely supplemental oxygen 4180, is delivered to one or more points in the pneumatic path (such as upstream of pneumatic block 4020), air circuit 4170 and / or patient interface 3000.

[0396] 4.6 Humidifier

[0397] 4.6.1 Overview of Humidifiers

[0398] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A (As shown), to change the absolute humidity of the air or gas used to deliver to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0399] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering the humidified airflow. In some forms, such as Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0400] 4.6.2 Humidifier Components

[0401] 4.6.2.1 Water Storage Tank

[0402] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to maintain or retain a liquid (e.g., water) capacity for evaporation to humidify the airflow. The water reservoir 5110 may be configured to maintain a predetermined maximum water capacity to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night's sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.

[0403] According to one aspect, the water reservoir 5110 is configured to increase the humidity of an airflow from the RPT device 4000 as airflow passes through it. In one form, the water reservoir 5110 may be configured to facilitate the airflow's travel in a curved path through the reservoir 5110 while in contact with the water volume therein.

[0404] According to one form, the storage 5110 can, for example, be along such a path. Figure 5A and Figure 5B The lateral direction shown is removed from the humidifier 5000.

[0405] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any hole and / or between its sub-components, when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent loss of pneumatic pressure due to leakage and / or flow resistance.

[0406] 4.6.2.2 Conducting section

[0407] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes are equally applicable. All or part of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., with a thickness of approximately 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity may be achieved using materials with appropriate geometries and lower thermal conductivity.

[0408] 4.6.2.3 Humidifier reservoir dock

[0409] In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 5B As shown), it is configured to receive a humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include a locking mechanism, such as a locking lever 5135 configured to hold the reservoir 5110 in the humidifier reservoir base 5130.

[0410] 4.6.2.4 Water level indicator

[0411] The humidifier storage unit 5110 may include, for example: Figures 5A-5B The water level indicator 5150 is shown. In some forms, the water level indicator 5150 may provide a user (such as a patient 1000 or a caregiver) with one or more indications regarding the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0412] 4.7 Respiratory waveform

[0413] Figure 6A The diagram shows a typical respiratory waveform of a sleeping human. The horizontal axis represents time, and the vertical axis represents respiratory flow. Although parameter values ​​can vary, typical breathing can be approximated by the following: tidal volume Vt 0.5 L, inspiratory time Ti 1.6 s, and peak inspiratory flow rate Q. 峰 0.4 L / s, expiratory time Te 2.4 s, peak expiratory flow Q 峰 -0.5 L / s. The total duration of respiration, Ttot, is approximately 4 seconds. Humans typically breathe at a rate of approximately 15 breaths per minute (BPM) with a ventilation rate of approximately 7.5 L / min. The typical duty cycle, Ti to Ttot, is approximately 40%.

[0414] 4.8 Breathing Therapy Mode

[0415] The disclosed respiratory therapy system enables various respiratory therapy modalities, including CPAP and bilayer therapy.

[0416] 4.9 General Rules

[0417] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0418] Environment: In some forms of this technology, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0419] For example, the ambient humidity relative to a humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's sleeping room. This ambient humidity can differ from the humidity outside the patient's sleeping room.

[0420] In another example, environmental stress can be stress that is directly around the body or outside the body.

[0421] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or transmitted from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0422] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SDB event.

[0423] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between the patient's different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of an indication of partial upper airway obstruction.

[0424] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, that is, a quantity that only has a magnitude. In other cases, the reference to flow rate will be a vector quantity, that is, a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated as 'flow' or 'airflow'.

[0425] In the context of patient breathing, flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd is the air flow rate leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv is the air flow rate leaving the ventilator to allow flushing of exhaled air. Leakage flow rate Ql is the leakage flow rate from the patient interface system or elsewhere. Respiratory flow rate Qr is the air flow rate received into the patient's respiratory system.

[0426] Flow therapy: Breathing therapy, which involves delivering a flow of air to the airway inlet at a controlled flow rate known as the therapeutic flow rate, which is generally positive throughout the patient’s respiratory cycle.

[0427] Humidifier: The term humidifier is considered to refer to a humidification device that is constructed and arranged or configured to have a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve the patient’s medical respiratory condition.

[0428] Leakage: The term leakage is used to describe undesirable airflow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in a swivel bend leading to the surrounding environment.

[0429] Noise, conducted (acoustic): In this document, conducted noise refers to noise delivered to the patient through pneumatic pathways, such as air circuits and patient interfaces, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0430] Noise, radiated (acoustic): Radiated noise in this document refers to noise delivered to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0431] Noise, ventilation (acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any ventilation opening (such as a ventilation opening for a patient interface).

[0432] Patient: A person, regardless of whether they have a respiratory illness.

[0433] Pressure: Force per unit area. Pressure can be expressed in units of area, including cmH2O and gf / cm². 2 1000 Pascals. 1 cmH2O equals 1 g-f / cm³ 2And it is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m² = 1 millibar to 0.001 atmospheres (atm)). In this specification, unless otherwise stated, pressure is given in cm H₂O.

[0434] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0435] Respiratory pressure therapy (RPT): Applying air supply to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.

[0436] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0437] 4.9.1.1 Materials

[0438] Silicone or silicone elastomer: a synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0439] Polycarbonate: is a thermoplastic polymer of bisphenol A carbonate.

[0440] 4.9.1.2 Mechanical Properties

[0441] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0442] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain siloxanes and thermoplastic elastomers.

[0443] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or an indentation hardness scale measured on a standardized sample size).

[0444] 'Soft' materials may include silicone or thermoplastic elastomers (TPEs) and may be easily deformed, for example, under finger pressure.

[0445] 'Hard' materials can include polycarbonate, polypropylene, steel or aluminum, and can be, for example, not easily deformed under finger pressure.

[0446] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. A structure or component can provide different resistance in different directions. The reciprocal of stiffness is flexibility.

[0447] Flexible structures or components: structures or components that will change shape (e.g., bend) when subjected to a relatively short period of time, such as 1 second, to support their own weight.

[0448] Rigid structures or components: Structures or components that do not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway at a pressure of approximately 20 to 30 cmH2O.

[0449] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.

[0450] 4.9.2 Respiratory and Circulatory Systems

[0451] Apnea: According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway prevents airflow even with patient effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is open. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0452] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0453] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0454] Effort (breathing): The work done by a spontaneously breathing person in trying to breathe.

[0455] The expiratory phase of the respiratory cycle: the time period from the start of expiratory flow rate to the start of inspiratory flow rate.

[0456] Flow restriction: Flow restriction is considered a state in a patient's breathing where increased effort by the patient does not result in a corresponding increase in flow. When flow restriction occurs during the inspiratory portion of the respiratory cycle, it can be described as inspiratory flow restriction.

[0457] When flow restriction occurs during the expiratory portion of the respiratory cycle, it can be described as expiratory flow restriction.

[0458] Types of flow-limited inhalation waveforms:

[0459] (i) Flattened: has an upward movement followed by a relatively flat section, and then...

[0460] decline.

[0461] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat section between the two peaks.

[0462] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0463] (iv) Inverted chair shape: with a relatively flat section followed by a single local peak at the trailing edge.

[0464] Insufficient breathing: By some definitions, insufficient breathing is considered a reduction in flow rate, rather than a cessation of flow. In one form, insufficient breathing can be considered to occur when the flow rate drops below a threshold rate for a sustained period of time. Central insufficient breathing is considered to occur when insufficient breathing is detected due to a reduction in respiratory effort. In one form for adults, any of the following can be considered insufficient breathing:

[0465] (i) The patient’s respiratory rate decreases by 30% for at least 10 seconds plus a related 4% desaturation; or

[0466] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% desaturation or arousal.

[0467] Hyperventilation: Increased airflow to above normal levels.

[0468] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow rate to the start of expiratory flow rate is considered the inspiratory portion of the respiratory cycle.

[0469] Airway openness: The degree to which the airway is open or the extent to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, with a value (1) for open and a value of zero (0) for closed (obstructed).

[0470] Positive end-expiratory pressure (PEEP): Pressure above atmospheric pressure present in the lungs at the end of expiration.

[0471] Peak flow (Qpeak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0472] Respiratory flow, patient air flow, and respiratory air flow (Qr): These terms can be understood as the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0473] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (volume of air inhaled) equals the expiratory volume Ve (volume of air exhaled), so a single tidal volume Vt can be defined as equal to either volume. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.

[0474] (Inhalation) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0475] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0476] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of a subsequent respiratory flow waveform.

[0477] Typical recent ventilation: The recent values ​​of ventilation (Vent) tend to cluster around their respective values ​​within a predetermined time range, which is a measure of the central tendency of recent ventilation values.

[0478] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases as the pressure differential in the upper airway increases (Starling resistance behavior).

[0479] Ventilation: A measurement of the flow rate of gases exchanged by a patient's respiratory system. A measurement of ventilation can include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0480] 4.9.3 Ventilation

[0481] Adaptive Servo Ventilator (ASV): A servo ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be determined from some characteristics of the patient, such as the patient's breathing characteristics.

[0482] Standby rate: A parameter of the ventilator that determines the minimum respiratory rate (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous breathing effort.

[0483] Cyclic: Termination of the inspiratory phase of a ventilator cycle. When a ventilator delivers breaths to a spontaneously breathing patient, the ventilator cycle is considered to have ended at the end of the inspiratory portion of the respiratory cycle.

[0484] Expiratory positive airway pressure (EPAP): The base pressure to which the pressure changes within the respiratory tract are added to produce the desired interface pressure that the ventilator will attempt to achieve at a given time.

[0485] End-expiratory pressure (EEP): The desired interface pressure that the ventilator attempts to achieve at the end of the expiratory phase. If the pressure waveform template Π(Φ) is zero at the end of expiration, i.e., when Φ = 1, Π(Φ) = 0, then EEP equals EPAP.

[0486] Inspiratory positive airway pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory phase of breathing.

[0487] Pressure support: A number indicating the increase in pressure during inspiration that exceeds the pressure during expiration, and generally refers to the pressure difference between the maximum pressure during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference the ventilator is designed to achieve, rather than the difference it actually achieves.

[0488] Servo ventilator: A ventilator that measures a patient's ventilation volume, has a target ventilation volume, and adjusts the level of pressure support to enable the patient to achieve the target ventilation volume.

[0489] Spontaneous / Timed (S / T): A mode of operation for a ventilator or other device that attempts to detect the onset of spontaneous breathing in a patient. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0490] Oscillation: A term equivalent to pressure support.

[0491] Triggered: When a ventilator delivers breathing air to a patient who is breathing spontaneously, it is considered to be triggered at the start of the respiratory phase of the respiratory cycle through the patient's effort.

[0492] 4.9.4 Anatomy

[0493] 4.9.4.1 Facial Anatomy

[0494] Alar: The outermost wall or "wing" of each nostril (plural: alar). Alar tip: The outermost point on the alar.

[0495] Nasal wing curve (or nasal apex) point: the last point on the baseline of each nasal wing curve, found in the crease formed by the junction of the nasal wing and the cheek.

[0496] Auricle: The entire visible external part of the ear.

[0497] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0498] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0499] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0500] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (the two lines intersect at the lower point of the nasal septum).

[0501] Frankfurt Plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0502] The glabella (between the eyebrows): Located on the soft tissue, it is the most prominent point in the sagittal plane at the midline of the forehead.

[0503] Lateral nasal cartilage: a cartilaginous plate that is basically triangular in shape. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0504] Lip, lower lip (midpoint of the lower lip):

[0505] Lip, upper lip (midpoint of the upper lip):

[0506] Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilages. It curves around the front of the nostrils. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane comprising three or four smaller cartilages, including the alar.

[0507] Nostrils (or nasal eyes): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril (nare) is nasal nasal (naris). The nostrils are separated by the nasal septum.

[0508] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0509] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0510] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0511] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0512] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0513] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0514] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0515] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0516] Sagittal plane: A vertical plane running from front to back. The midsagittal plane is the sagittal plane that divides the body into the right and left halves.

[0517] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0518] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0519] Posterosuperior lateral lamina: the point at the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper (superior) lip.

[0520] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0521] Supramental point: The point on the midline of the lower lip where the greatest concavity occurs between the midpoint of the lower lip and the premental point of the soft tissue.

[0522] 4.9.4.2 Anatomical Structure of the Skull

[0523] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0524] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0525] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral boundary.

[0526] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary from individual to individual; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0527] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.

[0528] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval-shaped foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0529] The eye socket is the bony cavity in the skull that houses the eyeball.

[0530] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0531] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0532] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the protrusions of the cheeks.

[0533] 4.9.4.3 Anatomical Structure of the Respiratory System

[0534] Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0535] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0536] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0537] Nasal chambers: The nasal chambers (or nasal fossae) are large, air-filled spaces located in the middle of the face above and behind the nose. The nasal chambers are divided into two parts by vertical wings called the nasal septum. On the sides of the nasal chambers are three horizontal branches called nasal conchae (singular "concha"). The front of the nasal chambers is the nose, while the back connects to the nasopharynx via the internal nasal openings.

[0538] Pharynx: The part of the throat located below the nasal cavity and above the esophagus and larynx. The pharynx is routinely divided into three segments: the nasopharynx (hyperpharynx), the oropharynx (middle pharynx), and the laryngopharynx (hypopharynx).

[0539] 4.9.5 Patient Interface

[0540] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0541] Elbow: An elbow is an example of a structure that guides the axis of an airflow traveling through it to change direction by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. An elbow can have an approximately circular cross-section. In another form, an elbow can have an elliptical or rectangular cross-section. In some forms, the elbow can rotate relative to the mating component, for example, about 360 degrees. In some forms, the elbow can be removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the elbow can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0542] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more points of connection with the head strap. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0543] Headband: A headband is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headband may include an assembly of one or more support bars, straps, and reinforcements configured to position and hold the patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, resilient materials, such as laminated composites of foam and fabric.

[0544] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0545] Inflation chamber: The mask inflation chamber is considered to refer to the portion of the patient interface having walls that at least partially enclose a volume of space, which, during use, contains air pressurized therein to above atmospheric pressure. A housing may form part of the wall of the mask inflation chamber.

[0546] Sealing: can be the noun form of a structure (sealant) or the verb form of the effect (seal). Two elements can be constructed and / or arranged to 'seal' or to achieve 'sealing' between them, without the need for a separate 'sealing' element itself.

[0547] Shell: A shell is considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0548] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0549] Support: The support will be considered as a structural component designed to increase the compressibility of another component in at least one direction.

[0550] Rotary shaft: (noun) a sub-component of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotary shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assemblies of the component preferably comprise a pair of mating cylindrical ducts. During use, there may be little or no airflow leakage from the rotary shaft.

[0551] Lacing (noun): A structure designed to resist tension.

[0552] Ventilation port: (noun): A structure that allows airflow from inside the mask or tubing to ambient air, for example, to effectively flush out exhaled gases. For example, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0553] 4.9.6 Shape of the structure

[0554] Products according to this technology may include one or more three-dimensional mechanical structures, such as mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a surface that contacts the face (e.g., the exterior) and separate surfaces that do not contact the face (e.g., the underside or interior). In yet another instance, a structure may include a first surface and a second surface.

[0555] To aid in describing the shape of three-dimensional structures and surfaces, we first consider a cross-section through a point p on the surface of the structure, see [reference needed]. Figures 3B to 3F They show the cross-section at point p on the surface and an example of the resulting planar curve. Figures 3B to 3F The outward normal vector at point p is also shown. The outward normal vector at p points away from the surface. In some examples, the surface is depicted from the viewpoint of an imaginary little person standing upright on the surface.

[0556] 4.9.6.1 Curvature in one dimension

[0557] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at p).

[0558] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if you imagine little figures leaving point p, they must walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to a relatively small positive curvature). Such curves are often referred to as concave.

[0559] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if you imagine a little person leaving point p, they can walk horizontally without going up or down). See also Figure 3D .

[0560] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if you imagine little figures leaving point p, they must go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are usually called convex.

[0561] 4.9.6.2 Curvature of Two-Dimensional Surfaces

[0562] A description of the shape at a given point on a two-dimensional surface according to the present invention may include multiple normal cross sections. These cross sections may cut through the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs.

[0563] Each curvature at that point has, for example, a relatively small amplitude. Figures 3B to 3F A planar curve in a diagram can be an example of multiple cross-sections at a specific point.

[0564] Principal curvature and principal direction: The direction of the normal plane to which the curvature of the curve reaches its maximum and minimum values ​​is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, the minimum curvature appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross section in the principal direction. The principal curvature at point p is the curvature in the principal direction.

[0565] A region of a surface: a connected set of points on the surface. This set of points in a region can have similar characteristics, such as curvature or sign.

[0566] Saddle-shaped region: a region in which the principal curvature has opposite signs at each point, i.e., one sign is positive and the other sign is negative (which may be going up or down depending on the direction the imagined individual is turning).

[0567] Dome region: A region in which the principal curvature has the same sign at each point, such as two positive ("concave dome") or two negative ("convex dome").

[0568] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is not zero.

[0569] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0570] Surface edge: The boundary or limit of a surface or region.

[0571] Path: In some forms of this technique, 'path' will be considered to mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, 'path' can be described as a route or distance, including, for example, a set of points on a surface. (The path of an imaginary person is the place where they walk on the surface, and is similar to a garden path).

[0572] Path length: In some forms of this technique, 'path length' will be considered as the distance along the surface from f(0) to f(1), i.e., the distance along the path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length for an imaginary person would be the distance they must walk along the path on the surface.)

[0573] Straight-line distance: Straight-line distance is the distance between two points on a surface, without considering the surface itself. On a planar region, there will exist paths on the surface with the same length as the straight-line distance between the two points. On a non-planar surface, there may not be any paths with the same length as the straight-line distance between the two points.

[0574] (For the imaginary person, straight-line distance will correspond to "in a straight line" distance)

[0575] 4.9.6.3 Space Curves

[0576] Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, that is, without endpoints. A space curve can be thought of as a one-dimensional segment of three-dimensional space. Imagine a person walking along a space curve on one strand of a DNA helix. The typical human left ear contains the helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3Q The typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a spatial curve. Typically, a spatial curve can be described by the curvature and torsion at each point on the curve. Torque is a measure of how the curve turns out of the plane. Torque has a sign and magnitude.

[0577] The twist at a point on a space curve can be characterized by the tangent vector, normal vector, and double normal vector at that point.

[0578] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If a hypothetical person were flying along the curve and falling from their aircraft at a specific point, the direction of the tangent vector would be the direction they would have traveled.

[0579] Unit normal vector: This tangent vector changes as an imaginary person moves along the curve. The unit vector pointing in the direction of the tangent vector's change is called the principal normal vector. It is perpendicular to the tangent vector.

[0580] A double-normal unit vector is a vector that is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, [link to relevant documentation]). Figure 3P ) or optionally by left-hand rule ( Figure 3O To determine.

[0581] Oscillating plane: The plane containing the unit tangent vector and the unit principal normal vector. See Appendix. Figure 3O and 3P .

[0582] Twist of a space curve: The twist of a space curve at a point is the magnitude of the rate of change of the unit vector of the binormal at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve lying in the osculating plane has zero twist. A space curve deviating relatively small from the osculating plane will have a relatively small amount of twist (e.g., a gently sloping spiral path). A space curve deviating relatively large from the osculating plane will have a relatively large amount of twist (e.g., a sharply sloping spiral path). See also Figure 3S Since T2 > T1, the amount of twist near the top coil of the spiral in Figure 3 is greater than that of T1. Figure 3S The amount of twist of the bottom coil of the spiral.

[0583] Reference Figure 3P According to the right-hand rule, a space curve oriented towards the right-hand binormal direction can be considered to have a right-hand positive twist (e.g., Figure 3S(The right-handed spiral is shown). A space curve that turns away from the direction of the right-hand double normal can be considered to have a right-handed negative twist (e.g., a left-handed spiral).

[0584] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve oriented towards the left-hand double normal direction can be considered to have a left-hand positive twist (e.g., a left-hand spiral). Therefore, left-hand positive is equivalent to right-hand negative. See also Figure 3T .

[0585] 4.9.6.4 holes

[0586] Surfaces can have one-dimensional pores, such as pores defined by planar curves or spatial curves. Thin structures with pores (e.g., films) can be described as having one-dimensional pores. See, for example, [example missing]. Figure 3I The structure shown has a one-dimensional hole in the surface bounded by a planar curve.

[0587] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a bladder having cavities for air or gel can have two-dimensional pores. See, for example, [link to relevant documentation]. Figure 3L padding and through Figure 3M and Figure 3N An exemplary cross-section is shown, illustrating the inner surface defining a two-dimensional orifice. In yet another example, a conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the inner surface of the conduit. See also Figure 3K The structure shown has a two-dimensional hole whose boundary is defined by the surface shown.

[0588] 4.10 Other Remarks

[0589] This patent document contains a portion of copyrighted material. The copyright holder does not object to anyone copying the patent document or patent disclosure by fax, as shown in the patent office's patent documents or records, but otherwise retains all copyright.

[0590] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly included within this technique. The upper and lower limits of these intermediate ranges may be included independently within the intermediate range and also within the scope of this technique, but are subject to any explicitly excluded boundaries within the range. Where a range includes one or both of the limit values, this technique also includes ranges that exclude any one or both of those included limit values.

[0591] Furthermore, where one or more values ​​are stated herein as part of the implementation of the technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used with any suitable significant figure to the extent that the actual implementation of the technology may allow or require.

[0592] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology pertains. While any methods and materials similar to or equivalent to those described herein may also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0593] When a particular material is set for use in constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0594] It must be noted that, unless the context clearly specifies otherwise, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents.

[0595] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. This document should not be construed as an admission that the present technology is not entitled to any prior disclosure due to a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0596] The terms “comprises” and “comprising” should be understood as referring to each element, component, or step in a non-exclusive manner, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.

[0597] The headings included in the detailed description are for the reader's convenience only and should not be used to limit the subject matter found throughout the disclosure or claims. These headings should not be used to interpret the claims or limit their scope.

[0598] Although the techniques described herein have been illustrated with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may imply specific details not required for the practice of the techniques. For example, although the terms “first” and “second” may be used, they are not intended to indicate any order unless otherwise stated, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects may be performed simultaneously or even concurrently.

[0599] Therefore, it should be understood that many modifications can be made to the illustrative examples and other devices can be designed without departing from the spirit and scope of this technology.

[0600] 4.11 List of Selected Reference Symbols

[0601]

[0602]

[0603]

[0604]

[0605]

Claims

1. A patient interface comprising: An air chamber that can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure; It has at least three inlet ports for the air chamber, sized and designed to receive airflow under therapeutic pressure for the patient's breathing. A sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening therein such that an airflow under the therapeutic pressure is delivered at least to the inlet of the patient's nostrils, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use, and A positioning and stabilizing structure includes at least four straps, at least three of which define channels therein, wherein a conduit is provided within each channel, and each conduit includes an interface connector for connecting the conduit to a corresponding inlet port in use. The positioning and stabilizing structure further includes a connection port for connecting to an air circuit in use, wherein the connection port is in fluid communication with each of the conduits. The inflation chamber is provided with at least one pressure measurement port.

2. The patient interface as claimed in claim 1, wherein each catheter has a diameter of 5 mm or less.

3. The patient interface of claim 1, wherein each strap comprises two layers of material, wherein the channel is disposed between the layers.

4. The patient interface of claim 3, wherein each strap includes a connector along one edge of the strap.

5. The patient interface of claim 3, wherein each strap includes a first connector along one edge of the strap and a second connector along the opposite edge of the strap.

6. The patient interface of claim 1, wherein each catheter is completely enclosed within its respective strap.

7. The patient interface of claim 1, wherein the catheter is detached from the strap.

8. The patient interface of claim 7, wherein the catheter does not function as an interface carrier.

9. The patient interface as described in claim 1, wherein, At least one inlet port includes a nasal inlet port and at least one inlet port includes an oral inlet port, the nasal inlet port and the oral inlet port being sized and configured to receive a corresponding airflow under therapeutic pressure for breathing by the patient.

10. The patient interface of claim 9, wherein the patient interface is configured such that the flow rate of air to the patient's nostrils is greater than the flow rate to the patient's mouth.

11. The patient interface of claim 9, wherein the impedance of the nasal inlet port is different from the impedance of the oral inlet port.

12. The patient interface of claim 9, comprising a plurality of nasal inlet ports and a plurality of oral inlet ports, wherein the combined impedance of the nasal inlet ports is less than the combined impedance of the oral inlet ports.

13. The patient interface of claim 9, wherein the flow rate through at least one inlet port is adjustable.

14. The patient interface of claim 13, wherein the flow rate through at least one inlet port is continuously adjustable.

15. The patient interface of claim 9, wherein at least one inlet port includes a flow limiter.

16. The patient interface of claim 15, wherein the current limiter is releasably connected to the patient interface.

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